Devices

Device Recall superDimension Bronchus System

  • Model / Serial
    All codes of disposable system components (Locatable Guide and Extended Working Channel).
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Austria, Belgium, Canada, France, Germany, Hungary, Israel, Italy, Netherlands, South Africa, Spain, Switzerland, Turkey, and United Kingdom.
  • Product Description
    Disposable components of the superDimension Bronchus System: Locatable Guide Kit (AKI00017-01) and Extended Working Channel (AKI00041-01).
  • Manufacturer
    SuperDimension, Inc.
  • 1 Event

Manufacturer

SuperDimension, Inc.
  • Manufacturer Address
    SuperDimension, Inc., 161 Cheshire Lane North, Suite 100, Minneapolis MN 55441
  • Source
    USFDA

One device with a similar name

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Device Recall superDimension Bronchus System
  • Model / Serial
    superDimension Bronchus System with the following serial numbers: S0030019, S030051, S030052, S030054, S030055, S030058 thru S030062, S030067, S030068, S030077 thru S030081; S030084, S030085, S030088 thru S030095; S030097 thru S030100, S030103, S030104, S030105, S030390, S030447, S030449, S0030009, S0030011, S0030013, S0030014, S0030015, S0030021, S0030022, S0030026, S0030042, S030043 thru S030050, S030053, S030056, S030057, S030063, S030064, S030066, S030069 thru S030076, S030082, S030086, S030087, S030096, S030102, S030477.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Austria, Belgium, Canada, France, Germany, Hungary, Israel, Italy, Netherlands, South Africa, Spain, Switzerland, Turkey, and United Kingdom.
  • Product Description
    superDimension Bronchus System (AAS00016-01), an image-guided localization system used to guide endoscopic tools to predetermined targets within the pulmonary tract.
  • Manufacturer
    SuperDimension, Inc.